Device and method for detecting an analyte in a bodily fluid using a test element

• US 10,031,067 B2
• Filed: 11/25/2015
• Issued: 07/24/2018
• Est. Priority Date: 07/20/2010
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Petrich, Wolfgang, Weidner, Frank
• Primary Examiner(s): LeGasse, Jr., Francis M
• Application Number:
  US14/952,683
• Publication Number:
  US 20160076993A1
• Time in Patent Office: 972 Days
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 5/151 Devices specially adapted for taking samples of capillary blood, e.g. by lancets , needles or blades
• CPC Class Codes: G01N 21/17 Systems in which incident light is modified in accordance with the properties of the material investigated where the material investigated is optically excited causing a change in wavelength of the incident light G01N21/63
• CPC Class Codes: G01N 21/78 producing a change of colour
• CPC Class Codes: G01N 21/8483 Investigating reagent band test-element handling not specific to a test method G01N33/4875; analytical elements specific to chemical analysis of biological material G01N33/52; autometer with reagent band G01N35/04
• CPC Class Codes: G01N 2201/0221 Portable; cableless; compact; hand-held
• CPC Class Codes: G01N 2201/12 Circuits of general importance; Signal processing
• CPC Class Codes: H01L 27/14601 Structural or functional details thereof

Abstract

A device is proposed for detecting at least one analyte in a bodily fluid. The device comprises at least one test element with at least one two-dimensional evaluation region. The device furthermore comprises at least one spatially resolving optical detector having a plurality of pixels. The detector is designed to image at least part of the test element onto an image region. In the process, at least part of the evaluation region is imaged onto an evaluation image region. The detector is matched to the test element such that a predetermined minimum number of pixels is provided for each dimension within the evaluation image region. The pixels are arranged in a two-dimensional matrix arrangement. The matrix arrangement has pixel rows and pixel columns, wherein the pixel rows are arranged substantially parallel to a longitudinal direction of the evaluation region and/or of the evaluation image region.

Claims

1. A device for detecting an analyte in a bodily fluid, comprising:

a test element having a two-dimensional evaluation region; and

a spatially resolving optical detector having a longitudinal side and a transverse side and a plurality of pixels, the detector being configured to image at least part of the test element that is positioned outside of the evaluation region onto an image region and to image at least part of the evaluation region onto an evaluation image region;

wherein;

the detector is matched to the test element such that a predetermined minimum number of pixels is provided for each dimension within the evaluation image region;

the pixels are arranged in a two-dimensional matrix having pixel rows and pixel columns;

the pixel rows are arranged substantially parallel to a longitudinal direction of the evaluation region and/or the evaluation image region; and

the detector has at least 3 pixel rows in the direction of the transverse side and at least 1 pixel column in the direction of the longitudinal side.

2. The device of claim 1, wherein the evaluation region is part of the test element and wherein the device is configured to transfer bodily fluid onto the test element for detecting the analyte.

3. The device of claim 1, further comprising a lancet element having a capillary, the capillary being configured to take up bodily fluid and the device being configured to cause the capillary to approach the test element to transfer bodily fluid onto the test element.

4. The device of claim 3, wherein, the evaluation region is a region of the test element in which an optically detectable change occurs as a result of transferring the bodily fluid onto the test element.

5. The device of claim 3, wherein the capillary has a width of 50-200 μ

m and a length of at least 1 mm.

6. The device according to claim 5, wherein the capillary has a width of 90-150 μ

m.

7. The device according to claim 5, wherein the capillary has a length of at least 2 mm.

8. The device according to claim 5, wherein the capillary has a length of 2-4 mm.

9. The device of claim 1, wherein the device is configured to recognize the evaluation region automatically.

10. The device as claimed in claim 9, wherein the device is configured to recognize the evaluation region according to one or more of the following:

a pattern recognition method, wherein the device comprises at least one element selected from the group consisting of at least one lancet element and at least one capillary, wherein, in the pattern recognition method, the element is recognized and an extrapolation of the element onto the test element is identified as the evaluation region;

a signal-change method, wherein a region of the test element within which an optically detectable change occurs as a result of a transfer of the bodily fluid onto the test element is identified as the evaluation region.

11. The device as claimed in claim 1, wherein the detector has a total number of no more than 1000 pixels.

12. The device as claimed in claim 11, wherein the detector has a total number of no more than 500 pixels.

13. The device as claimed in claim 11, wherein the detector has a total number of no more than 256 pixels.

14. The device as claimed in claim 1, wherein the evaluation region has a longitudinal side and a transverse side, wherein the detector has at least 3 pixel rows in the direction of the transverse side of the evaluation region and at least 1 pixel column in the direction of the longitudinal side of the evaluation region.

15. The device as claimed in claim 14, wherein the longitudinal side of the evaluation region is aligned parallel to a capillary of the device and the transverse side is arranged perpendicular to the capillary.

16. The device as claimed in claim 14, wherein the detector has 3-10 pixel rows in the direction of the transverse side of the evaluation region and 3-10 pixel columns in the direction of the longitudinal side of the evaluation region.

17. The device as claimed in claim 14, wherein the detector has no more than 100 pixel rows in the direction of the transverse side of the evaluation region.

18. The device as claimed in claim 14, wherein the detector has 3-10 pixel rows in the direction of the transverse side of the evaluation region.

19. The device as claimed in claim 14, wherein the detector has at least 3 pixel columns in the direction of the longitudinal side of the evaluation region.

20. The device as claimed in claim 14, wherein the detector has 3-10 pixel columns in the direction of the longitudinal side of the evaluation region.

21. The device of claim 1, wherein at least 3 pixels are arranged in the evaluation region.

22. The device of claim 21, wherein 5-30 pixels are arranged in the evaluation region.

23. The device as claimed in claim 1, wherein the pixels have an elongate pixel geometry, wherein the evaluation region has a longitudinal side and a transverse side, wherein the pixels have a length in the direction of the longitudinal direction of the evaluation region and wherein the pixels have a width in the direction of the transverse side of the evaluation region, wherein the length exceeds the width.

24. The device as claimed in claim 23, wherein the longitudinal side of the evaluation region is aligned parallel to the capillary and the transverse side of the evaluation region is arranged perpendicular to the capillary.

25. The device as claimed in claim 23, wherein the length exceeds the width by at least a factor of 1.3.

26. The device as claimed in claim 23, wherein the length exceeds the width by at least a factor of 1.7.

27. The device as claimed in claim 23, wherein the length exceeds the width by at least a factor of 2.

28. The device of claim 1, wherein the detector has a spatially resolving optical unit configured to image the evaluation region onto the evaluation image region with a magnification of 3:

1 to 0.5;

1.

29. The device as claimed in claim 28, wherein the spatially resolving optical unit is configured to image the evaluation region onto the evaluation image region with a magnification of 2:

1 to 0.8;

1.

30. The device as claimed in claim 28, wherein the spatially resolving optical unit is configured to image the evaluation region onto the evaluation image region with a magnification of 1.1:

1 to 0.9;

1.

31. The device of claim 1, wherein the device is configured to evaluate a wetting of the test element with the bodily fluid by comparing a plurality of pixels in at least one dimension.

32. The device of claim 31, wherein the device is configured to evaluate a wetting of the test element with the bodily fluid by comparing adjacent pixels of a pixel row aligned parallel to the evaluation region.

33. The device as claimed in claim 1, wherein the device is configured to recognize a blank value, wherein the blank value is an optical property of at least one of the image region or the evaluation image region, wherein the device is configured to determine the blank value by one or more of the following:

recording a temporal image sequence wherein at least one pixel arranged within the evaluation region is recognized and an initial value of the pixel is determined from the temporal image sequence and used as blank value;

an initial value of the pixels of the image region is stored, the evaluation region is established from a temporal image sequence of the pixels, pixels outside of the evaluation region are discarded and at least one initial value of a pixel within the evaluation region is used as blank value;

the evaluation region is established and at least one pixel from outside of the evaluation region is used as blank value.

36. The method according to claim 34, further comprising using the device as claimed in claim 1.

37. The device of claim 1, wherein the detector has no more than 100 pixel rows in the direction of the transverse side.

38. The device of claim 1, wherein the detector has 20-50 pixel rows in the direction of the transverse side.

39. The device of claim 1, wherein the detector has 2-20 pixel columns in the direction of the longitudinal side.

40. The device of claim 1, wherein the detector has 5-10 pixel columns in the direction of the longitudinal side.

34. A method for recognizing an evaluation region of a test element for detecting at least one analyte in a bodily fluid, comprising:

transferring bodily fluid onto the test element;

using a spatially resolved optical detector to image at least part of the test element onto an image region;

imaging at least part of an evaluation region of the test element onto an evaluation image region; and

automatically recognizing the evaluation region by at least one of;

a pattern recognition method in which at least one element selected from the group consisting of the lancet element and the capillary is recognized and an extrapolation of the element onto the test element is identified as the evaluation region;

or

a signal-change method in which a region of the test element within which an optically detectable change occurs as a result of the transfer of the bodily fluid onto the test element is identified as the evaluation region.

35. The method of claim 34, further comprising providing a lancet element with a capillary and drawing bodily fluid into the capillary.